Photobiomodulation in Gingival Graft Donor Areas: Clinical, Somatosensory, and Quality of Life Evaluations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Somatosensory recovery
研究概览
简要总结
The goal of this clinical trial is to compare the effects of photobiomodulation with red laser on gingival graft donor areas of the palate in comparison to only protection with wound dressing. The main questions it aims to answer are: Does photobiomodulation on the palate promote faster somatosensory recovery? Does photobiomodulation reduce pain in palate donor sites, improving the quality of life? Participants who need gingival graft surgeries will receive laser irradiation on the palate donor area or just protection with wound dressing. Data will be collected up to 60 days. Researchers will compare protection on the palate and protection plus laser irradiation to see if laser therapy may reduce pain and accelerate somatosensory normalization. Moreover, they will measure changes in the quality of life after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients will be masked by using a sham laser. Outcomes assessor will not be able to identify the experimental groups
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Palate with normal and healthy mucosa
- •Patient with indication of gingival graft surgery
排除标准
- •Patients using prosthesis with palate coverage
- •Former removal of gingival graft in the palate
- •Pregnancy and breastfeeding mothers
- •Use of anticonvulsants and immunosuppressors
研究组 & 干预措施
Photobiomodulation
Red laser irradiation on palate wound at the day of the surgery and after 2, 4 and 6 days postoperatively. Protection of wound with surgical dressing during 7 days.
干预措施: Photobiomodulation (Other)
Control
Protection of wound with surgical dressing during 7 days.
干预措施: Protection with surgical dressing (Other)
结局指标
主要结局
Somatosensory recovery
时间窗: 30 and 60 days postoperatively
Mechanical and pain detection threshold measured with Von Frey filaments
次要结局
- Assessment of Pain(24 hours, 3 days, 7 days and 14 days)
- Measurement of Quality of life(Baseline, 7 days and 14 days postoperatively)
研究者
Carla Andreotti Damante
Associate professor
University of Sao Paulo